Orgalutran

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ganirelix

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Orgalutran. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Orgalutran.

This EPAR was last updated on 04/04/2023

Authorisation details

Product details
Name
Orgalutran
Agency product number
EMEA/H/C/000274
Active substance
ganirelix
International non-proprietary name (INN) or common name
ganirelix
Therapeutic area (MeSH)
  • Reproductive Techniques, Assisted
  • Ovulation Induction
  • Infertility, Female
Anatomical therapeutic chemical (ATC) code
H01CC01
Publication details
Marketing-authorisation holder
N.V. Organon
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
16/05/2000
Contact address

Kloosterstraat 6
5349 AB Oss
The Netherlands

Product information

20/03/2023 Orgalutran - EMEA/H/C/000274 - N/0056

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Pituitary and hypothalamic hormones and analogues

Therapeutic indication

The prevention of premature luteinising-hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques.

In clinical studies, Orgalutran was used with recombinant human follicle-stimulating hormone or corifollitropin alfa, the sustained follicle stimulant.

Assessment history

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